MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

Model Number	70516SI
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the 8 foley catheters contained debris, hair and black specks within the sterile wrapper.As per follow up via phone on 20sep2022, stated that the catheters did not come into contact with any patients.
Event or Problem Description
It was reported that the 8 foley catheters contained debris, hair and black specks within the sterile wrapper.Per follow up via phone on 20sep2022, stated that the catheters did not come into contact with any patients.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample exhibited the reported failure.The device had not met specifications.The reported failure is considered out of specification as the reported failure was reproduced.The product was not used for patient treatment or diagnosis.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), 8 unopened 3-way catheters.Visual inspection noted foreign material inside of the catheter packaging.This is out of specification per inspection procedure which states, loosen hair in package and/or trapped in sealing is not allowed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15476240
• Report Number: 1018233-2022-07409
• Device Sequence Number: 6005322
• Product Code: MJC
• UDI-Device Identifier: 00801741025433
• UDI-Public: (01)00801741025433
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2025
• Device Model Number: 70516SI
• Device Catalogue Number: 70516SI
• Device Lot Number: NGGP1223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 02/19/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown